Murphy Tanya K, Brennan Erin M, Johnco Carly, Parker-Athill Ellisa Carla, Miladinovic Branko, Storch Eric A, Lewin Adam B
1 Department of Pediatrics, Rothman Center for Neuropsychiatry, University of South Florida , St. Petersburg, Florida.
2 Department of Psychiatry & Behavioral Sciences, University of South Florida , St. Petersburg, Florida.
J Child Adolesc Psychopharmacol. 2017 Sep;27(7):640-651. doi: 10.1089/cap.2016.0190. Epub 2017 Mar 30.
Sudden and severe onset of obsessive-compulsive disorder (OCD) may present secondary to infectious and/or immune-mediated triggers. We assessed the preliminary efficacy, tolerability, and safety of azithromycin compared with placebo in the treatment of OCD and associated symptoms in children with pediatric acute-onset neuropsychiatric syndrome (PANS).
Thirty-one youth aged 4-14 years (M = 8.26 ± 2.78 years, 62.5% male) were randomized to receive either placebo or azithromycin for 4 weeks (10 mg/kg up to 500 mg per day). Both groups were administered twice daily probiotics. The primary outcome, obsessive-compulsive symptom severity, was assessed using the OCD Clinical Global Impressions Severity (CGI-S OCD) and Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS).
Participants in the azithromycin group (n = 17) showed significantly greater reductions in OCD severity on the CGI-S OCD than the placebo group (n = 14) posttreatment (p = 0.003), although there were no significant differences on the CY-BOCS. Significantly more participants in the azithromycin condition met treatment responder criteria on the CGI-I OCD at the end of week 4 (41.2%, n = 7) in comparison to the placebo group (7.1%, n = 1; p = 0.045). Tic severity moderated treatment response, with greater tic severity being associated with enhanced treatment response on the CGI-S OCD. Azithromycin was well tolerated with minimal adverse effects and no study dropouts due to side effects. However, the azithromycin group showed a trend toward significantly greater electrocardiography QTc (p = 0.060) at the end of week 4, and significantly more reports of loose or abnormal stools (p = 0.009).
This double blind pilot study suggests that azithromycin may be helpful in treating youth meeting the PANS diagnosis, especially those with elevated levels of both OCD and tic symptoms. Azithromycin was well tolerated, but the potential for cardiac risks suggests that additional monitoring may be needed to ensure safety.
强迫症（OCD）的突然和严重发作可能继发于感染和/或免疫介导的触发因素。我们评估了阿奇霉素与安慰剂相比，在治疗患有小儿急性起病神经精神综合征（PANS）的儿童强迫症及相关症状方面的初步疗效、耐受性和安全性。
31名4 - 14岁的青少年（平均年龄M = 8.26 ± 2.78岁，62.5%为男性）被随机分为两组，分别接受安慰剂或阿奇霉素治疗4周（每天10mg/kg，最大剂量500mg）。两组均每日两次服用益生菌。主要结局指标，即强迫症状严重程度，使用强迫症临床总体印象严重程度量表（CGI - S OCD）和儿童耶鲁 - 布朗强迫量表（CY - BOCS）进行评估。
阿奇霉素组（n = 17）在治疗后，CGI - S OCD量表上的强迫症严重程度较安慰剂组（n = 14）有显著更大程度的降低（p = 0.003），尽管在CY - BOCS量表上无显著差异。在第4周结束时，阿奇霉素组达到CGI - I OCD治疗反应标准的参与者显著多于安慰剂组（41.2%，n = 7）（安慰剂组为7.1%，n = 1；p = 0.045）。抽动严重程度调节了治疗反应，抽动严重程度越高，在CGI - S OCD量表上的治疗反应越好。阿奇霉素耐受性良好，不良反应轻微，且无因副作用导致的研究脱落情况。然而，阿奇霉素组在第4周结束时心电图QTc有显著升高的趋势（p = 0.060），且腹泻或大便异常的报告显著更多（p = 0.009）。
这项双盲试验研究表明，阿奇霉素可能有助于治疗符合PANS诊断的青少年，尤其是那些强迫症和抽动症状水平均升高的患者。阿奇霉素耐受性良好，但存在心脏风险，这表明可能需要额外监测以确保安全。
